Preoperative Lugol's Solution in Graves' Disease and Toxic Nodular Goiter

February 6, 2026 updated by: Jan Calissendorff
The purpose of this study is to assess if preoperative treatment with Lugol's solution prior to thyroidectomy can reduce the surgical complications hypoparathyroidism and laryngeal nerve palsy

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Current practice in Sweden before thyroidectomy due to hyperthyroidism is preoperative treatment with antithyroid drugs (ATD) to all patients with Graves' disease and in cases of toxic nodular goiter with pronounced hyperthyroidism. Iodine solution is administered preoperatively in selected cases of Graves' disease where ATD is intolerable. In the cases where iodine is used it is in the form of extemporaneous prepared iodine potassium iodide solution (Lugol 5%). The dose varies in clinical studies. In American and Swedish guidelines the dose is 5-10 drops 3 times per day for 10 days prior to surgery. American guidelines recommend iodine as preoperative treatment i Graves' disease but this is based on sparse evidence. Iodine as preoperative treatment in toxic nodular goiter has yet not been studied.

The purpose of this study is to assess if preoperative treatment with Lugol's solution prior to thyroidectomy due to hyperthyroidism reduce the surgical complications hypoparathyroidism and laryngeal nerve palsy.

Before including toxic nodular goiters accepted for surgery, a pilot study will be performed on 20 patients with toxic nodular goiter. They will receive Lugol solution 3 times per day for ten days and thyroid hormone levels will be measured day 0, day 3-4, day 6-7 and after 10 days of Lugol treatment. Heart rate assessed and ThyPRO39 filled out before and after treatment.

Study Type

Interventional

Enrollment (Estimated)

182

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Hyperthyroidism accepted for thyroidectomy due to toxic nodular goiter with free T4 <30 pmol/L or Graves' disease
  • Signed informed consent

Exclusion Criteria:

  • Unstable coronary artery disease
  • Previous thyroid surgery
  • Congestive heart failure
  • Renal insufficiency
  • Hepatic failure
  • Current infection
  • Treatment with steroids or anticoagulants
  • Thyroid associated orbitopathy CAS > 2
  • Diabetes mellitus type 1
  • Active cancer
  • Severe psychiatric illness
  • Amiodarone treatment
  • Pregnancy
  • Breast feeding
  • Women of child bearing potential not using contraceptive
  • Inability to comprehend the meaning of the study
  • Iodine hypersensitivity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iodine Potassium Iodide solution
Participants receive Iodine Potassium Iodide solution oral drops 3 times per day for 10 Days prior to thyroidectomy in addition to standard preoperative treatment
Drug: Iodine-Potassium Iodide 5%-10% Oral and Topical Solution
Iodine Potassium Iodide 5% oral solution, administered 3 times per day for 10 days
Other Names:
  • Lugol's solution
No Intervention: No intervention
Participants continue with standard preoperative treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temporary hypoparathyroidism
Time Frame: 1 month postoperatively
Numbers of participants with signs of hypoparathyroidism measured as hypocalcemia, low parathormone (PTH), supplementation with per oral vitamin D or calcium.
1 month postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temporary laryngeal nerve palsy
Time Frame: 1 month postoperatively
Number of patients with postoperative signs of vocal chord damage via clinical assessment or laryngoscopy.
1 month postoperatively
Permanent laryngeal nerve palsy
Time Frame: 6 months postoperatively
Number of patients with postoperative signs of vocal chord damage via clinical assessment or laryngoscopy.
6 months postoperatively
Permanent hypoparathyroidism
Time Frame: 6 months postoperatively
Numbers of participants with signs of hypoparathyroidism measured as hypocalcemia, low PTH, supplementation with per oral vitamin D or calcium.
6 months postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Quality of Life on the Thyroid Specific Patient Reported Outcome 39 (ThyPRO 29) questionnaire
Time Frame: 6 months postoperatively
ThyPRO 39 is a validated thyroid specific Quality of Life form. Self reported questionnaire filled out before and after surgery. ThyPRO consists of 39 items grouped in 11 scales. Each item is is rated from 0 to 5 on a 5 point Likert scale. Increasing scores indicating decreasing quality of life. Lower scores indicating better quality of life.
6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jan Calissendorff

Investigators

  • Principal Investigator: Jan Calissendorff, MD, PhD, Department of Molecular Medicine and Surgery, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2021

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

April 6, 2021

First Submitted That Met QC Criteria

April 19, 2021

First Posted (Actual)

April 23, 2021

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LugolProtocol001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The original contributions presented in the study are included in the article/supplementary material.

IPD Sharing Time Frame

The original contributions presented in the study are included in the article/supplementary material. Inquiries can be directed to the corresponding author after publication.

IPD Sharing Access Criteria

Further inquiries can be directed to the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hyperthyroidism

Clinical Trials on Iodine-Potassium Iodide 5%-10% Oral and Topical Solution

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe